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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05680272
Other study ID # TRKMARAS46
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 15, 2023
Est. completion date October 30, 2024

Study information

Verified date November 2023
Source Kahramanmaras Sutcu Imam University
Contact Sultan ALAN
Phone 05066646919
Email tasalann@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

it was aimed to determine the effect of empathic communication-based education on positive birth perception awareness.


Description:

Since the existence of humanity, women have not been left alone during pregnancy, childbirth and postpartum period in all societies, but have been supported by their environment. In providing this support, midwives have important responsibilities as the primary responsible health professional . Quality midwifery care given at birth is very important for women to have a positive birth experience The biggest expectations of mothers from midwives in the birth and postpartum period are; it is approaching with empathetic communication such as smiling, therapeutic touch, listening, speaking in a language that the pregnant can understand, making oneself feel good, encouraging, informing, paying attention to privacy. Mothers whose expectations are met in labor; It can have positive obstetric outcomes such as shortening the delivery time, reduction in analgesia and medical intervention applications, positive birth experience, initiation of breastfeeding in the early period, mother-infant bonding and transition to the role of motherhood . İt will contribute positively to the health indicators of the country and reduce the cost, a scale and guide have been prepared within the scope of this thesis, with the foresight that pregnant women and health workers need training materials, and training with interactive and mobile communication tools in this direction. has been planned.It is expected that the training to be given in line with the developed guideline, and the empathic communication-based training given in the third trimester of pregnancy will help to increase the awareness of women's positive perception of birth. With this study, it was aimed to determine the effect of empathic communication-based education on positive birth perception awareness.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date October 30, 2024
Est. primary completion date September 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - 18 years and older pregnancy - Speaks and understands Turkish - Able to read and write, - Having a single fetus, - Not having a risky pregnancy, - 32-36. in gestational week, - Pregnant women who do not have any disability diagnosed for normal delivery Exclusion Criteria: - Risky pregnant women - Pregnant women with communication difficulties - Pregnant women with mental deficiency

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
empathic communication-based education
The study will consist of two stages. The first stage will be methodological in order to develop the Positive Birth Perception Awareness Scale based on Empathic Communication, and the second stage will be a trial model with a pretest-posttest control group in order to determine the effect of the training given to pregnant women based on empathic communication on positive birth perception awareness and birth experience.

Locations

Country Name City State
Turkey Kahramanmaras Sütçü Imam Universty Kahramanmaras

Sponsors (1)

Lead Sponsor Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (21)

. Senoglu, A., & Karaçam, Z. Opinions and Needs of Birth Supporters on Participation in Birth. Dokuz Eylül University Faculty of Nursing Electronic Journal, 2019;12(4), 274-282.

Aktas S, Pasinlioglu T. The effect of empathy training given to midwives on the empathic communication skills of midwives and the birth satisfaction of mothers giving birth with the help of these midwives: A quasi-experimental study. J Eval Clin Pract. 20 — View Citation

Biaggi A, Conroy S, Pawlby S, Pariante CM. Identifying the women at risk of antenatal anxiety and depression: A systematic review. J Affect Disord. 2016 Feb;191:62-77. doi: 10.1016/j.jad.2015.11.014. Epub 2015 Nov 18. — View Citation

Bogale B, Morkrid K, Abbas E, Abu Ward I, Anaya F, Ghanem B, Hijaz T, Isbeih M, Issawi S, A S Nazzal Z, E Qaddomi S, Froen JF. The effect of a digital targeted client communication intervention on pregnant women's worries and satisfaction with antenatal c — View Citation

Buchanan L, Anderson E, MBiostat HX, Phongsavan P, Rissel C, Wen LM. Sources of information and the use of mobile applications for health and parenting information during pregnancy: Implications for health promotion. Health Informatics J. 2021 Jul-Sep;27( — View Citation

Cevik A, Alan S. Mental Health and Diseases for Midwives. Ed. Alan S. Pregnancy and Postpartum Period. Ankara; Academician Bookstore, 2019.

Dökmen Ü. Communication conflicts and empathy. 48th edition. Istanbul: Remzi Bookstore,2012.

Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146. — View Citation

Gaskin IM. Ina May's Birth Preparation Guide. Erkök EE, Guler ZB (Transl). 1st edition. Istanbul: Sinek Eight Publishing House,2015.

Haapio S, Kaunonen M, Arffman M, Astedt-Kurki P. Effects of extended childbirth education by midwives on the childbirth fear of first-time mothers: an RCT. Scand J Caring Sci. 2017 Jun;31(2):293-301. doi: 10.1111/scs.12346. Epub 2016 Jul 21. — View Citation

International Confederation of Midwives. Essential competencies for basic midwifery Practice 2018.URL:https://internationalmidwives.org/assets/uploads/documents/CoreDocuments/ENG%20Definition_of_the_Midwife%202017.p df. 20 Nisan 2018.

Karacam Z, Akyüz EÖ. Supportive care given in labor and the role of the midwife/nurse. FNJN 2011;19(1):45-5.

Lazzaretto E, Nespoli A, Fumagalli S, Colciago E, Perego S, Locatelli A. Intrapartum care quality indicators: a literature review. Minerva Ginecol. 2018 Jun;70(3):346-356. doi: 10.23736/S0026-4784.17.04177-6. Epub 2017 Nov 21. — View Citation

Lea J, Cruickshank M. Supporting new graduate nurses making the transition to rural nursing practice: views from experienced rural nurses. J Clin Nurs. 2015 Oct;24(19-20):2826-34. doi: 10.1111/jocn.12890. Epub 2015 Jul 14. — View Citation

Navaee M, Abedian Z. Effect of role play education on primiparous women's fear of natural delivery and their decision on the mode of delivery. Iran J Nurs Midwifery Res. 2015 Jan-Feb;20(1):40-6. — View Citation

Oladapo OT, Tuncalp O, Bonet M, Lawrie TA, Portela A, Downe S, Gulmezoglu AM. WHO model of intrapartum care for a positive childbirth experience: transforming care of women and babies for improved health and wellbeing. BJOG. 2018 Jul;125(8):918-922. doi: — View Citation

Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Ryding EL, Saisto T. Group psychoeducation with relaxation for severe fear of childbirth improves maternal adjustment and childbirth experience--a randomised controlled trial. J Psychosom Obstet — View Citation

Rouhe H, Salmela-Aro K, Toivanen R, Tokola M, Halmesmaki E, Saisto T. Obstetric outcome after intervention for severe fear of childbirth in nulliparous women - randomised trial. BJOG. 2013 Jan;120(1):75-84. doi: 10.1111/1471-0528.12011. Epub 2012 Nov 2. — View Citation

Ryding EL, Lukasse M, Parys AS, Wangel AM, Karro H, Kristjansdottir H, Schroll AM, Schei B; Bidens Group. Fear of childbirth and risk of cesarean delivery: a cohort study in six European countries. Birth. 2015 Mar;42(1):48-55. doi: 10.1111/birt.12147. — View Citation

Toohill J, Callander E, Gamble J, Creedy DK, Fenwick J. A cost effectiveness analysis of midwife psycho-education for fearful pregnant women - a health system perspective for the antenatal period. BMC Pregnancy Childbirth. 2017 Jul 11;17(1):217. doi: 10.1 — View Citation

Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501. — View Citation

* Note: There are 21 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Positive Birth Perception Awareness Scale Positive Birth Perception Awareness Scale (PDAFS): Focus group interviews will be held with 10-12 pregnant women for the scale to be developed. An item pool will be created from the themes and sub-areas obtained from the interviews. In addition, the factors affecting the awareness of positive birth perception of pregnant women were examined by examining the national and international literature, and a form will be prepared for the pilot study. The scale form, the literature study of the researchers and the findings of the focus group interviews will be re-evaluated and the pilot study form of the scale will be prepared. The pilot study form will be submitted to the expert opinion. The pilot form will be sent to 10-12 experts. By making arrangements in line with expert opinions, the question pool will be finalized before the application, and it will be transformed into a 5-point Likert scale model baseline
Secondary Wijma Birth Experience/Expectation Scale A (WBBSS-A) The scale consists of 33 items. The answers in the scale are in six-point Likert type numbered from 0 to 5. 0 is evaluated as "totally" and 5 as "not at all". The lowest score obtained from the scale is 0 and the highest score is 165. These; Those who have low level of fear of childbirth (WBLSS score = 37), those who have moderate fear of childbirth (WBBSS-A score between 38-65). baseline
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